Encore Medical, LP Recalls Reverse Shoulder Prosthesis Humeral Socket Inserts Due to Incorrect Labeling

Source: FDA · United States

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Encore Medical, LP has issued a voluntary recall for 20 Reverse Shoulder Prosthesis (RSP) humeral socket inserts because the implants contain incorrect labeling.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Encore Medical, LP has initiated a voluntary recall of specific Reverse Shoulder Prosthesis (RSP) humeral socket inserts. The recall was triggered after it was discovered that certain knee and humeral socket implants were distributed with incorrect labeling. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall involves 20 units of the following medical device:

  • Brand Name: Reverse Shoulder Prosthesis (RSP)
  • Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus
  • Model/Catalog Number: 509-00-432
  • Lot Code: 385P1263
  • GTIN: 00888912144575

These products were distributed to healthcare facilities in the following states: VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.

What You Should Do

Encore Medical, LP notified affected customers via a formal letter initiated on January 15, 2026. Healthcare providers and facilities should check their inventory for the specific lot code (385P1263) and follow the instructions provided in the firm's notification letter regarding the return or quarantine of the affected implants. For additional information, parties may contact Encore Medical, LP at their Austin, Texas location.

Why This Matters

Incorrect labeling on medical implants like the Reverse Shoulder Prosthesis can lead to the selection of improper components during surgery. This poses a risk to patient safety and may impact the success of the prosthetic procedure.

Source

FDA Recall Z-1458-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Encore Medical, LP has issued a voluntary recall for 20 Reverse Shoulder Prosthesis (RSP) humeral socket inserts because the implants contain incorrect labeling.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.